# PNP: Dental Abutment Design Software For Dental Laboratory

- Device class: 2; regulation: 21 CFR 872.3630; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 457 days (middle half 415–493)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 1
- 2019: 1
- 2020: 2
- 2021: 1
- 2023: 1
- 2024: 2

## Most-cited predicates
- K151455: 3Shape Abutment Designer Software (2016), cited by 4
- K200100: Abutment Design (2020), cited by 3

Source page: https://510kreport.com/product-code/PNP
Data by year (CSV): https://510kreport.com/product-code/PNP.csv